Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study
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Protocol summary
The design is a multicenter clinical trial that will be conducted in 14 centers all over the country.
The design is a multicenter clinical trial that will be conducted in 20 centers all over the country.
The design is a multicenter clinical trial that will be conducted in 1420 centers all over the country.
این طرح یک کارآزمایی بالینی چند مرکزی میباشد که در 14 مرکز در سطح کشور انجام خواهد شد.
این طرح یک کارآزمایی بالینی چند مرکزی میباشد که در 20 مرکز در سطح کشور انجام خواهد شد.
این طرح یک کارآزمایی بالینی چند مرکزی میباشد که در 1420 مرکز در سطح کشور انجام خواهد شد.
Admission to intensive care unit, In-hopital mortality, length of stay in hospital, Radiological Treatment Response (CT scan), Laboratory Treatment Response (return of blood cell count and CRP values to normal) Fever, Dyspnea, Oxygen saturation after discontinuation of supplemental oxygen for 5 minutes, Oxygen therapy maximum flow during the day (lit/min), and Adverse and allergic drug reactions
Admission to intensive care unit, In-hopital mortality, length of stay in hospital, Radiological Treatment Response (CT scan), Laboratory Treatment Response (return of blood cell count and CRP values to normal) , Clinical improvement, Oxygen saturation after discontinuation of supplemental oxygen for 5 minutes, Oxygen therapy maximum flow during the day (lit/min), and Adverse and allergic drug reactions
Admission to intensive care unit, In-hopital mortality, length of stay in hospital, Radiological Treatment Response (CT scan), Laboratory Treatment Response (return of blood cell count and CRP values to normal) Fever, DyspneaClinical improvement, Oxygen saturation after discontinuation of supplemental oxygen for 5 minutes, Oxygen therapy maximum flow during the day (lit/min), and Adverse and allergic drug reactions
میزان بستری در بخش مراقبت های ویژه، مرگ در بیمارستان، طول مدت بستری، پاسخ به درمان بر اساس معیارهای رادیولوژیک (CT اسکن) ، پاسخ به درمان آزمایشگاهی، برگشت شمارش گلبولهای خونی و CRP به حد نرمال، تب، تنگی نفس، اشباع اکسیژن بدون دریافت اکسیژن برای 5 دقیقه، دریافت اکسیژن بصورت حداکثر میزان دریافتی در روز لیتر در دقیقه، میزان عوارض و واکنش های حساسیت دارویی و الرژیک
میزان بستری در بخش مراقبت های ویژه، مرگ در بیمارستان، طول مدت بستری، پاسخ به درمان بر اساس معیارهای رادیولوژیک (CT اسکن) ، پاسخ به درمان آزمایشگاهی، برگشت شمارش گلبولهای خونی و CRP به حد نرمال، بهبود وضعیت بالینی، اشباع اکسیژن بدون دریافت اکسیژن برای 5 دقیقه، دریافت اکسیژن بصورت حداکثر میزان دریافتی در روز لیتر در دقیقه، میزان عوارض و واکنش های حساسیت دارویی و الرژیک
میزان بستری در بخش مراقبت های ویژه، مرگ در بیمارستان، طول مدت بستری، پاسخ به درمان بر اساس معیارهای رادیولوژیک (CT اسکن) ، پاسخ به درمان آزمایشگاهی، برگشت شمارش گلبولهای خونی و CRP به حد نرمال، تب، تنگی نفسبهبود وضعیت بالینی، اشباع اکسیژن بدون دریافت اکسیژن برای 5 دقیقه، دریافت اکسیژن بصورت حداکثر میزان دریافتی در روز لیتر در دقیقه، میزان عوارض و واکنش های حساسیت دارویی و الرژیک
General information
Actual trial started one day earlier and more centers added
As knowledge of the disease increased, one secondary outcome was added and two secondary outcome were removed. Also, 7 centers were added.
Actual trial startedAs knowledge of the disease increased, one day earliersecondary outcome was added and moretwo secondary outcome were removed. Also, 7 centers were added.
تاریخ شروع کارآزمایی یک روز زودتر آغاز می شود و تعداد مراکز نیز اضافه شدند
با افزایش دانش در خصوص بیماری، یک پیامد ثانویه اضافه و 2 پیامد ثانویه حذف شد. همچنین 7 مرکز بیمارگیری اضافه شد.
تاریخ شروع کارآزماییبا افزایش دانش در خصوص بیماری، یک روز زودتر آغاز می شودپیامد ثانویه اضافه و تعداد مراکز نیز2 پیامد ثانویه حذف شد. همچنین 7 مرکز بیمارگیری اضافه شدندشد.
Health conditions studied
#1
COVID-19
U07.1
COVID-19U07.1
U07.1 COVID-19
COVID-19
U07.1 COVID-19
Secondary outcomes
#1
Fever
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
FeverOxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
تب
اشباع اکسیژن بدون دریافت اکسیژن. 5 دقیقه بعد از قطع اکسیژن اندازه گیری انجام می شود.
تباشباع اکسیژن بدون دریافت اکسیژن. 5 دقیقه بعد از قطع اکسیژن اندازه گیری انجام می شود.
Daily
4 times a day while in the wards
Daily4 times a day while in the wards
روزانه
چهار بار در روز ، هر روز در طول بستری در بخش
روزانهچهار بار در روز ، هر روز در طول بستری در بخش
Patient medical records
Observation
Patient medical recordsObservation
مشاهده پرونده بیمار
مشاهده
مشاهده پرونده بیمار
#2
Dyspnea
Oxygen therapy maximum flow during the day (lit/min)
DyspneaOxygen therapy maximum flow during the day (lit/min)
تنگی نفس
دریافت اکسیژن بصورت حداکثر میزان دریافتی در روز لیتر در دقیقه
تنگی نفسدریافت اکسیژن بصورت حداکثر میزان دریافتی در روز لیتر در دقیقه
#3
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Allergic drug reaction
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.Allergic drug reaction
اشباع اکسیژن بدون دریافت اکسیژن. 5 دقیقه بعد از قطع اکسیژن اندازه گیری انجام می شود.
میزان واکنش های حساسیت دارویی و الرژیک
اشباع اکسیژن بدون دریافت اکسیژن. 5 دقیقه بعد از قطع اکسیژن اندازه گیری انجام می شود.میزان واکنش های حساسیت دارویی و الرژیک
4 times a day while in the wards
Daily
4 times a day while in the wardsDaily
چهار بار در روز ، هر روز در طول بستری در بخش
روزانه
چهار بار در روز ، هر روز در طول بستری در بخشروزانه
Observation
Adverse Drug Reaction forms
ObservationAdverse Drug Reaction forms
مشاهده
فرم های عوارض دارویی
مشاهدهفرم های عوارض دارویی
#4
Oxygen therapy maximum flow during the day (lit/min)
Adverse drug reactions
Oxygen therapy maximum flow during the day (lit/min)Adverse drug reactions
دریافت اکسیژن بصورت حداکثر میزان دریافتی در روز لیتر در دقیقه
میزان عوارض دارویی
دریافت اکسیژن بصورت حداکثر میزان دریافتی در روز لیتر در دقیقهعوارض دارویی
Patient medical records
Adverse Drug Reaction forms
Patient medical recordsAdverse Drug Reaction forms
مشاهده پرونده بیمار
فرم های عوارض دارویی
مشاهده پرونده بیمارفرم های عوارض دارویی
#5
Allergic drug reaction
Clinical improvement
Allergic drug reactionClinical improvement
میزان واکنش های حساسیت دارویی و الرژیک
بهبود بالینی
میزان واکنش های حساسیت دارویی و الرژیکبهبود بالینی
Adverse Drug Reaction forms
One of the following may happen to the patient: Oxygen saturation reaches above 93% and stays above 93%, the patient does not need oxygen therapy and stays in the same position, discharge by the treating physician
Adverse Drug Reaction formsOne of the following may happen to the patient: Oxygen saturation reaches above 93% and stays above 93%, the patient does not need oxygen therapy and stays in the same position, discharge by the treating physician
فرم های عوارض دارویی
یکی از موارد زیر برای بیمار اتفاق بیفتد: برگشت اشباع اکسیژن به بالای 93% و ماندن در بالای 93%، عدم نیاز بیمار به اکسیژن درمانی و ماندن در همین وضعیت، ترخیص توسط پزشک معالج
فرم های عوارض دارویییکی از موارد زیر برای بیمار اتفاق بیفتد: برگشت اشباع اکسیژن به بالای 93% و ماندن در بالای 93%، عدم نیاز بیمار به اکسیژن درمانی و ماندن در همین وضعیت، ترخیص توسط پزشک معالج
#6
Adverse drug reactions
empty
Adverse drug reactions
میزان عوارض دارویی
empty
میزان عوارض دارویی
Daily
empty
Daily
روزانه
empty
روزانه
Adverse Drug Reaction forms
empty
Adverse Drug Reaction forms
فرم های عوارض دارویی
empty
فرم های عوارض دارویی
Recruitment centers
#1
Name of recruitment center - English: Emam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Dr Hossein Khalili
Full name of responsible person - Persian: دکتر حسین خلیلی
Street address - English: Tehran, Keshavarz Bulevard
Street address - Persian: تهران، بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 8860 0067
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Firoozgar Hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Dr Farhad Zamani
Full name of responsible person - Persian: دکتر فرهاد زمانی
Street address - English: Valiasr Square, Karimkhan Bulevard., Behafarin st.,
Street address - Persian: میدان ولی عصر، بلوار کریم خان زند، خیابان به آفرین
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1809
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Emam KhomeiniFiroozgar Hospital Name of recruitment center - Persian: بیمارستان امام خمینیفیروزگر Full name of responsible person - English: Dr Hossein KhaliliFarhad Zamani Full name of responsible person - Persian: دکتر حسین خلیلیفرهاد زمانی Street address - English: TehranValiasr Square, KeshavarzKarimkhan Bulevard., Behafarin st., Street address - Persian: تهرانمیدان ولی عصر، بلوار کشاورزکریم خان زند، خیابان به آفرین City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14197331411593747811 Phone: +98 21 8860 00678214 1809 Fax: Email: biganeh75@gmail.com Web page address:
#2
Name of recruitment center - English: Firoozgar Hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Dr Farhad Zamani
Full name of responsible person - Persian: دکتر فرهاد زمانی
Street address - English: Valiasr Square, Karimkhan Bulevard., Behafarin st.,
Street address - Persian: میدان ولی عصر، بلوار کریم خان زند، خیابان به آفرین
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1809
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم
Full name of responsible person - English: Dr Saeid Kalantari
Full name of responsible person - Persian: دکتر سعید کلانتری
Street address - English: Satarkhan, Niayesh St., Maziar Mansouri St.,
Street address - Persian: ستارخان، خیابان نیایش، منصوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 1000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: FiroozgarRasoul Akram Hospital Name of recruitment center - Persian: بیمارستان فیروزگررسول اکرم Full name of responsible person - English: Dr Farhad ZamaniSaeid Kalantari Full name of responsible person - Persian: دکتر فرهاد زمانیسعید کلانتری Street address - English: Valiasr SquareSatarkhan, Karimkhan BulevardNiayesh St., Behafarin stMaziar Mansouri St., Street address - Persian: میدان ولی عصر، بلوار کریم خان زندستارخان، خیابان به آفریننیایش، منصوری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 15937478111445613131 Phone: +98 21 8214 18096435 1000 Fax: Email: biganeh75@gmail.com Web page address:
#3
Name of recruitment center - English: Masih Daneshvari Hospital
Name of recruitment center - Persian: بیمارستان مسیح دانشوری
Full name of responsible person - English: Dr Farzaneh Dastan
Full name of responsible person - Persian: دکتر فرزانه داستان
Street address - English: Niavaran, Bahonar St., DarAbad
Street address - Persian: نیاوران، خیابان شهید باهنر، دارآباد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1956944413
Phone: +98 21 2712 3000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Isfahan Khorshid Hospital
Name of recruitment center - Persian: بیمارستان خورشید اصفهان
Full name of responsible person - English: Dr Ramin Sami
Full name of responsible person - Persian: دکتر رامین سامی
Street address - English: 8 Behehst St, Ostandari St
Street address - Persian: هشت بهشت، خ استانداری
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 03132222127
Phone: +98 31 3222 2127
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Masih DaneshvariIsfahan Khorshid Hospital Name of recruitment center - Persian: بیمارستان مسیح دانشوریخورشید اصفهان Full name of responsible person - English: Dr Farzaneh DastanRamin Sami Full name of responsible person - Persian: دکتر فرزانه داستانرامین سامی Street address - English: Niavaran8 Behehst St, BahonarOstandari St., DarAbad Street address - Persian: نیاورانهشت بهشت، خیابان شهید باهنر، دارآبادخ استانداری City - English: TehranIsfahan City - Persian: تهراناصفهان Province: TehranIsfehan Country: Iran (Islamic Republic of) Postal code: 195694441303132222127 Phone: +98 21 2712 300031 3222 2127 Fax: Email: biganeh75@gmail.com Web page address:
#4
Name of recruitment center - English: Rasoul Akram Hospital
Name of recruitment center - Persian: بیمارستان رسول اکرم
Full name of responsible person - English: Dr Saeid Kalantari
Full name of responsible person - Persian: دکتر سعید کلانتری
Street address - English: Satarkhan, Niayesh St., Maziar Mansouri St.,
Street address - Persian: ستارخان، خیابان نیایش، منصوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 1000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Shahid Beheshti
Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
Full name of responsible person - English: Dr Mansooreh Momen Heravi
Full name of responsible person - Persian: دکتر منصوره مومن هروی
Street address - English: Qotb ravandi Bulevard
Street address - Persian: بلوار قطب راوندی
City - English: Isfahan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715981151
Phone: +98 31 5554 0026
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Rasoul Akram HospitalShahid Beheshti Name of recruitment center - Persian: بیمارستان رسول اکرمشهید بهشتی کاشان Full name of responsible person - English: Dr Saeid KalantariMansooreh Momen Heravi Full name of responsible person - Persian: دکتر سعید کلانتریمنصوره مومن هروی Street address - English: Satarkhan, Niayesh St., Maziar Mansouri St.,Qotb ravandi Bulevard Street address - Persian: ستارخان، خیابان نیایش، منصوریبلوار قطب راوندی City - English: TehranIsfahan City - Persian: تهرانکاشان Province: TehranIsfehan Country: Iran (Islamic Republic of) Postal code: 14456131318715981151 Phone: +98 21 6435 100031 5554 0026 Fax: Email: biganeh75@gmail.com Web page address:
#5
Name of recruitment center - English: Isfahan Khorshid Hospital
Name of recruitment center - Persian: بیمارستان خورشید اصفهان
Full name of responsible person - English: Dr Ramin Sami
Full name of responsible person - Persian: دکتر رامین سامی
Street address - English: 8 Behehst St, Ostandari St
Street address - Persian: هشت بهشت، خ استانداری
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 03132222127
Phone: +98 31 3222 2127
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Kosar Hospital
Name of recruitment center - Persian: بیمارستان کوثر سمنان
Full name of responsible person - English: Dr Mohamad Memarian
Full name of responsible person - Persian: دکتر محمد معماریان
Street address - English: Golestan town
Street address - Persian: شهرک گلستان
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3519899951
Phone: +98 23 3142 0023
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Isfahan KhorshidKosar Hospital Name of recruitment center - Persian: بیمارستان خورشید اصفهانکوثر سمنان Full name of responsible person - English: Dr Ramin SamiMohamad Memarian Full name of responsible person - Persian: دکتر رامین سامیمحمد معماریان Street address - English: 8 Behehst St, Ostandari StGolestan town Street address - Persian: هشت بهشت، خ استانداریشهرک گلستان City - English: IsfahanSemnan City - Persian: اصفهانسمنان Province: IsfehanSemnan Country: Iran (Islamic Republic of) Postal code: 031322221273519899951 Phone: +98 31 3222 212723 3142 0023 Fax: Email: biganeh75@gmail.com Web page address:
#6
Name of recruitment center - English: Shahid Beheshti
Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشان
Full name of responsible person - English: Dr Mansooreh Momen Heravi
Full name of responsible person - Persian: دکتر منصوره مومن هروی
Street address - English: Qotb ravandi Bulevard
Street address - Persian: بلوار قطب راوندی
City - English: Isfahan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8715981151
Phone: +98 31 5554 0026
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Velaiat Hospital
Name of recruitment center - Persian: بیمارستان ولایت قزوین
Full name of responsible person - English: Dr Mariam Qaraati
Full name of responsible person - Persian: دکتر مریم قرائتی
Street address - English: Taavon Square
Street address - Persian: میدان تعاون
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 02833790610
Phone: +98 28 3379 0627
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Shahid BeheshtiVelaiat Hospital Name of recruitment center - Persian: بیمارستان شهید بهشتی کاشانولایت قزوین Full name of responsible person - English: Dr Mansooreh Momen HeraviMariam Qaraati Full name of responsible person - Persian: دکتر منصوره مومن هرویمریم قرائتی Street address - English: Qotb ravandi BulevardTaavon Square Street address - Persian: بلوار قطب راوندیمیدان تعاون City - English: IsfahanQazvin City - Persian: کاشانقزوین Province: IsfehanQazvin Country: Iran (Islamic Republic of) Postal code: 871598115102833790610 Phone: +98 31 5554 002628 3379 0627 Fax: Email: biganeh75@gmail.com Web page address:
#7
Name of recruitment center - English: Kosar Hospital
Name of recruitment center - Persian: بیمارستان کوثر سمنان
Full name of responsible person - English: Dr Mohamad Memarian
Full name of responsible person - Persian: دکتر محمد معماریان
Street address - English: Golestan town
Street address - Persian: شهرک گلستان
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3519899951
Phone: +98 23 3142 0023
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Emam khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام ساری
Full name of responsible person - English: Dr Roya Qasemian
Full name of responsible person - Persian: دکتر رویا قاسمیان
Street address - English: Imam Square, Vali Asr Highway
Street address - Persian: میدان امام، بزرگراه ولی عصر
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 01133361700
Phone: +98 11 3336 1700
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: KosarEmam khomeini Hospital Name of recruitment center - Persian: بیمارستان کوثر سمنانامام ساری Full name of responsible person - English: Dr Mohamad MemarianRoya Qasemian Full name of responsible person - Persian: دکتر محمد معماریانرویا قاسمیان Street address - English: Golestan townImam Square, Vali Asr Highway Street address - Persian: شهرک گلستانمیدان امام، بزرگراه ولی عصر City - English: SemnanSari City - Persian: سمنانساری Province: SemnanMazandaran Country: Iran (Islamic Republic of) Postal code: 351989995101133361700 Phone: +98 23 3142 002311 3336 1700 Fax: Email: biganeh75@gmail.com Web page address:
#8
Name of recruitment center - English: Velaiat Hospital
Name of recruitment center - Persian: بیمارستان ولایت قزوین
Full name of responsible person - English: Dr Mariam Qaraati
Full name of responsible person - Persian: دکتر مریم قرائتی
Street address - English: Taavon Square
Street address - Persian: میدان تعاون
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 02833790610
Phone: +98 28 3379 0627
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Labafinejad Hospital
Name of recruitment center - Persian: بیمارستان لبافی نژاد تهران
Full name of responsible person - English: Dr Shadi Ziaei
Full name of responsible person - Persian: دکتر شادی ضیایی
Street address - English: Pasdaran St, 9th Bostan St
Street address - Persian: خیابان پاسداران - خیابان بوستان نهم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1666663111
Phone: +98 21 2360 1000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: VelaiatLabafinejad Hospital Name of recruitment center - Persian: بیمارستان ولایت قزوینلبافی نژاد تهران Full name of responsible person - English: Dr Mariam QaraatiShadi Ziaei Full name of responsible person - Persian: دکتر مریم قرائتیشادی ضیایی Street address - English: Taavon SquarePasdaran St, 9th Bostan St Street address - Persian: میدان تعاونخیابان پاسداران - خیابان بوستان نهم City - English: QazvinTehran City - Persian: قزوینتهران Province: QazvinTehran Country: Iran (Islamic Republic of) Postal code: 028337906101666663111 Phone: +98 28 3379 062721 2360 1000 Fax: Email: biganeh75@gmail.com Web page address:
#9
Name of recruitment center - English: Emam khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام ساری
Full name of responsible person - English: Dr Roya Qasemian
Full name of responsible person - Persian: دکتر رویا قاسمیان
Street address - English: Imam Square, Vali Asr Highway
Street address - Persian: میدان امام، بزرگراه ولی عصر
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 01133361700
Phone: +98 11 3336 1700
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Dr Akram Asghari
Full name of responsible person - Persian: دکتر اکرم اصغری
Street address - English: Shahid Beheshti Boulevard
Street address - Persian: بلوار شهید بهشتی
City - English: Ghoum
City - Persian: شهر قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 3719964797
Phone: +98 25 3612 2000
Fax:
Email: akramasghari11@yahoo.com
Web page address:
Name of recruitment center - English: Emam khomeiniShahid Beheshti Hospital Name of recruitment center - Persian: بیمارستان امام ساریشهید بهشتی Full name of responsible person - English: Dr Roya QasemianAkram Asghari Full name of responsible person - Persian: دکتر رویا قاسمیاناکرم اصغری Street address - English: Imam Square, Vali Asr HighwayShahid Beheshti Boulevard Street address - Persian: میدان امام، بزرگراه ولی عصربلوار شهید بهشتی City - English: SariGhoum City - Persian: ساریشهر قم Province: MazandaranGhoum Country: Iran (Islamic Republic of) Postal code: 011333617003719964797 Phone: +98 11 3336 170025 3612 2000 Fax: Email: biganeh75akramasghari11@gmail.comyahoo.com Web page address:
#10
Name of recruitment center - English: Labafinejad Hospital
Name of recruitment center - Persian: بیمارستان لبافی نژاد تهران
Full name of responsible person - English: Dr Shadi Ziaei
Full name of responsible person - Persian: دکتر شادی ضیایی
Street address - English: Pasdaran St, 9th Bostan St
Street address - Persian: خیابان پاسداران - خیابان بوستان نهم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1666663111
Phone: +98 21 2360 1000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Forghani Hospital
Name of recruitment center - Persian: بیمارستان فرقانی
Full name of responsible person - English: Dr Abolfazl Mozafari
Full name of responsible person - Persian: دکتر ابوالفضل مظفری
Street address - English: Taleghani Street
Street address - Persian: خیابان طالقانی
City - English: Ghoum
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 37158
Phone: +98 25 3133 3000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: LabafinejadForghani Hospital Name of recruitment center - Persian: بیمارستان لبافی نژاد تهرانفرقانی Full name of responsible person - English: Dr Shadi ZiaeiAbolfazl Mozafari Full name of responsible person - Persian: دکتر شادی ضیاییابوالفضل مظفری Street address - English: Pasdaran St, 9th Bostan StTaleghani Street Street address - Persian: خیابان پاسداران - خیابان بوستان نهمطالقانی City - English: TehranGhoum City - Persian: تهرانقم Province: TehranGhoum Country: Iran (Islamic Republic of) Postal code: 166666311137158 Phone: +98 21 2360 100025 3133 3000 Fax: Email: biganeh75@gmail.com Web page address:
#11
Name of recruitment center - English: Shahid Beheshti Hospital
Name of recruitment center - Persian: بیمارستان شهید بهشتی
Full name of responsible person - English: Dr Akram Asghari
Full name of responsible person - Persian: دکتر اکرم اصغری
Street address - English: Shahid Beheshti Boulevard
Street address - Persian: بلوار شهید بهشتی
City - English: Ghoum
City - Persian: شهر قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 3719964797
Phone: +98 25 3612 2000
Fax:
Email: akramasghari11@yahoo.com
Web page address:
Name of recruitment center - English: Kamkar Hospital
Name of recruitment center - Persian: بیمارستان کامکار
Full name of responsible person - English: Dr Javad Khodadadi
Full name of responsible person - Persian: دکتر جواد خدادی
Street address - English: 19 Day Street
Street address - Persian: خیابان 19 دی
City - English: Ghoum
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 37759229
Phone: +98 25 3775 9229
Fax:
Email: biganeh75@yahoo.com
Web page address:
Name of recruitment center - English: Shahid BeheshtiKamkar Hospital Name of recruitment center - Persian: بیمارستان شهید بهشتیکامکار Full name of responsible person - English: Dr Akram AsghariJavad Khodadadi Full name of responsible person - Persian: دکتر اکرم اصغریجواد خدادی Street address - English: Shahid Beheshti Boulevard19 Day Street Street address - Persian: بلوار شهید بهشتیخیابان 19 دی City - English: Ghoum City - Persian: شهر قم Province: Ghoum Country: Iran (Islamic Republic of) Postal code: 371996479737759229 Phone: +98 25 3612 20003775 9229 Fax: Email: akramasghari11biganeh75@yahoo.com Web page address:
#12
Name of recruitment center - English: Forghani Hospital
Name of recruitment center - Persian: بیمارستان فرقانی
Full name of responsible person - English: Dr Abolfazl Mozafari
Full name of responsible person - Persian: دکتر ابوالفضل مظفری
Street address - English: Taleghani Street
Street address - Persian: خیابان طالقانی
City - English: Ghoum
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 37158
Phone: +98 25 3133 3000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital2
Name of recruitment center - Persian: بیمارستان رسول اکرم2
Full name of responsible person - English: Dr Zeinab Yasin
Full name of responsible person - Persian: دکتر زینب یاسین
Street address - English: Satarkhan, Niayesh St., Maziar Mansouri St.,
Street address - Persian: ستارخان، خیابان نیایش، منصوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 1000
Fax:
Email: biganeh75@gmail.com
Web page address:
Name of recruitment center - English: Forghani HospitalRasoul Akram Hospital2 Name of recruitment center - Persian: بیمارستان فرقانیرسول اکرم2 Full name of responsible person - English: Dr Abolfazl MozafariZeinab Yasin Full name of responsible person - Persian: دکتر ابوالفضل مظفریزینب یاسین Street address - English: Taleghani StreetSatarkhan, Niayesh St., Maziar Mansouri St., Street address - Persian: ستارخان، خیابان طالقانینیایش، منصوری City - English: GhoumTehran City - Persian: قمتهران Province: GhoumTehran Country: Iran (Islamic Republic of) Postal code: 371581445613131 Phone: +98 25 3133 300021 6435 1000 Fax: Email: biganeh75@gmail.com Web page address:
#13
Name of recruitment center - English: Kamkar Hospital
Name of recruitment center - Persian: بیمارستان کامکار
Full name of responsible person - English: Dr Javad Khodadadi
Full name of responsible person - Persian: دکتر جواد خدادی
Street address - English: 19 Day Street
Street address - Persian: خیابان 19 دی
City - English: Ghoum
City - Persian: قم
Province: Ghoum
Country: Iran (Islamic Republic of)
Postal code: 37759229
Phone: +98 25 3775 9229
Fax:
Email: biganeh75@yahoo.com
Web page address:
Name of recruitment center - English: Emam Reza Hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Dr Masoud Nazemieh
Full name of responsible person - Persian: دکتر مسعود ناظمیه
Street address - English: University Street, Golgasht Street
Street address - Persian: خیابان دانشگاه، خیابان گلگشت
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614756
Phone: +98 41 3334 7054
Fax:
Email: mnazemiyeh@yahoo.com
Web page address:
Name of recruitment center - English: KamkarEmam Reza Hospital Name of recruitment center - Persian: بیمارستان کامکارامام رضا Full name of responsible person - English: Dr Javad KhodadadiMasoud Nazemieh Full name of responsible person - Persian: دکتر جواد خدادیمسعود ناظمیه Street address - English: 19 DayUniversity Street, Golgasht Street Street address - Persian: خیابان 19 دیدانشگاه، خیابان گلگشت City - English: GhoumTabriz City - Persian: قمتبریز Province: GhoumEast Azarbaijan Country: Iran (Islamic Republic of) Postal code: 377592295166614756 Phone: +98 25 3775 922941 3334 7054 Fax: Email: biganeh75mnazemiyeh@yahoo.com Web page address:
#14
Name of recruitment center - English: Valiasr Hospital
Name of recruitment center - Persian: بیمارستان ولیعصر
Full name of responsible person - English: Dr Ahmad Reza Mobaien
Full name of responsible person - Persian: دکتر احمدرضا مبین
Street address - English: Valiasr Squre
Street address - Persian: میدان ولیعصر
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Country: Iran (Islamic Republic of)
Postal code: 7797845157
Phone: +98 24 3377 0801
Fax:
Email: Mobaien1@gmail.com
Web page address:
Name of recruitment center - English: Valiasr Hospital Name of recruitment center - Persian: بیمارستان ولیعصر Full name of responsible person - English: Dr Ahmad Reza Mobaien Full name of responsible person - Persian: دکتر احمدرضا مبین Street address - English: Valiasr Squre Street address - Persian: میدان ولیعصر City - English: Zanjan City - Persian: زنجان Province: Zanjan Country: Iran (Islamic Republic of) Postal code: 7797845157 Phone: +98 24 3377 0801 Fax: Email: Mobaien1@gmail.com Web page address:
#15
Name of recruitment center - English: Firoozabadi Hospital
Name of recruitment center - Persian: بیمارستان فیروزآبادی
Full name of responsible person - English: Dr Farshad Divsalar
Full name of responsible person - Persian: دکتر فرشاد دیوسالار
Street address - English: Fadaiyan-e-Islam Street
Street address - Persian: خیابان فدائیان اسلام
City - English: Rey city
City - Persian: شهر ری
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۵۵۹۰۰۲۴۳
Phone: +98 21 5104 8000
Fax:
Email: Dr.farshaddivsalar@gmail.com
Web page address:
Name of recruitment center - English: Firoozabadi Hospital Name of recruitment center - Persian: بیمارستان فیروزآبادی Full name of responsible person - English: Dr Farshad Divsalar Full name of responsible person - Persian: دکتر فرشاد دیوسالار Street address - English: Fadaiyan-e-Islam Street Street address - Persian: خیابان فدائیان اسلام City - English: Rey city City - Persian: شهر ری Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۵۵۹۰۰۲۴۳ Phone: +98 21 5104 8000 Fax: Email: Dr.farshaddivsalar@gmail.com Web page address:
#16
Name of recruitment center - English: Hajar Hospital
Name of recruitment center - Persian: بیمارستان هاجر
Full name of responsible person - English: Dr Reza Mosaed
Full name of responsible person - Persian: دکتر رضا مساعد
Street address - English: Valiasr St., Shahid Beheshti Intersection (Abbas Abad)
Street address - Persian: خیابان ولیعصر، تقاطع شهید بهشتی (عباس آباد)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 88710294
Phone: +98 21 8871 0294
Fax:
Email: reza.mosaed1990@gmail.com
Web page address:
Name of recruitment center - English: Hajar Hospital Name of recruitment center - Persian: بیمارستان هاجر Full name of responsible person - English: Dr Reza Mosaed Full name of responsible person - Persian: دکتر رضا مساعد Street address - English: Valiasr St., Shahid Beheshti Intersection (Abbas Abad) Street address - Persian: خیابان ولیعصر، تقاطع شهید بهشتی (عباس آباد) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 88710294 Phone: +98 21 8871 0294 Fax: Email: reza.mosaed1990@gmail.com Web page address:
#17
Name of recruitment center - English: Razi Hospital
Name of recruitment center - Persian: بیمارستان رازی
Full name of responsible person - English: Dr Lotfallah Davoodi
Full name of responsible person - Persian: دکتر لطف الله داوودی
Street address - English: Yousef Reza Street
Street address - Persian: خیابان یوسف رضا
City - English: Qaemshahr
City - Persian: قائمشهر
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4765686743
Phone: +98 11 4221 8018
Fax:
Email: lotfdavoodi@yahoo.com
Web page address:
Name of recruitment center - English: Razi Hospital Name of recruitment center - Persian: بیمارستان رازی Full name of responsible person - English: Dr Lotfallah Davoodi Full name of responsible person - Persian: دکتر لطف الله داوودی Street address - English: Yousef Reza Street Street address - Persian: خیابان یوسف رضا City - English: Qaemshahr City - Persian: قائمشهر Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: 4765686743 Phone: +98 11 4221 8018 Fax: Email: lotfdavoodi@yahoo.com Web page address:
#18
Name of recruitment center - English: Ganjavian Hospital
Name of recruitment center - Persian: بیمارستان گنجویان
Full name of responsible person - English: Dr Javad Moazen
Full name of responsible person - Persian: دکتر جواد موذن
Street address - English: Dezful Andimeshk Highway
Street address - Persian: بزرگراه دزفول اندیمشک
City - English: Dezful
City - Persian: دزفول
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6261684
Phone: +98 61 4242 2040
Fax:
Email: Dr.moazen@yahoo.com
Web page address:
Name of recruitment center - English: Ganjavian Hospital Name of recruitment center - Persian: بیمارستان گنجویان Full name of responsible person - English: Dr Javad Moazen Full name of responsible person - Persian: دکتر جواد موذن Street address - English: Dezful Andimeshk Highway Street address - Persian: بزرگراه دزفول اندیمشک City - English: Dezful City - Persian: دزفول Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6261684 Phone: +98 61 4242 2040 Fax: Email: Dr.moazen@yahoo.com Web page address:
#19
Name of recruitment center - English: Razi Hospital
Name of recruitment center - Persian: بیمارستان رازی
Full name of responsible person - English: Dr Maryam Haddadzadeh shoushtari
Full name of responsible person - Persian: دکتر مریم حدادزاده شوشتری
Street address - English: Palestine Street
Street address - Persian: خیابان فلسطین
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6196514941
Phone: +98 61 3333 5935
Fax:
Email: m.haddadzadeh_sh@yahoo.com
Web page address:
Name of recruitment center - English: Razi Hospital Name of recruitment center - Persian: بیمارستان رازی Full name of responsible person - English: Dr Maryam Haddadzadeh shoushtari Full name of responsible person - Persian: دکتر مریم حدادزاده شوشتری Street address - English: Palestine Street Street address - Persian: خیابان فلسطین City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6196514941 Phone: +98 61 3333 5935 Fax: Email: m.haddadzadeh_sh@yahoo.com Web page address:
Protocol summary
Study aim
Comparing safety and efficacy of Favipiravir and Kaletra in COVID-19
Design
Randomized parallel group, clinical trial, open label
Settings and conduct
The design is a multicenter clinical trial that will be conducted in 20 centers all over the country.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19; Requiring hospitalization; Patient's age between 16 and 100 years; Signed informed consent form; Exclusion criteria: Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir); Chronic liver or renal failure; HIV; GI bleeding; Pregnancy; Lactation; QT interval > 500 ms.
Intervention groups
Intervention group: Group receiving Favipiravir plus Hydroxychloroquine. Stat dose of eight 200 mg Favipiravir tablets (total 1600 mg) followed by Favipiravir 600 mg three times a day for 7 days plus Hydroxychloroquine 200mg two times per day for 7 days. Control group: Group receiving Kaletra plus Hydroxychloroquine regimen. Stat dose of two 200 mg Hydroxychloroquine tablets (total 400 mg) followed by Kaletra(Lopinavir/Ritonavir) 200/50 mg two times a day for 7 days.
Main outcome variables
Admission to intensive care unit, In-hopital mortality, length of stay in hospital, Radiological Treatment Response (CT scan), Laboratory Treatment Response (return of blood cell count and CRP values to normal) , Clinical improvement, Oxygen saturation after discontinuation of supplemental oxygen for 5 minutes, Oxygen therapy maximum flow during the day (lit/min), and Adverse and allergic drug reactions
General information
Reason for update
As knowledge of the disease increased, one secondary outcome was added and two secondary outcome were removed. Also, 7 centers were added.
Acronym
IRCT registration information
IRCT registration number:IRCT20200318046812N1
Registration date:2020-04-01, 1399/01/13
Registration timing:registered_while_recruiting
Last update:2020-08-05, 1399/05/15
Update count:6
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Mostafa Ghanei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 0067
Email address
mghaneister@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-01, 1399/01/13
Expected recruitment end date
2020-06-02, 1399/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of hydroxychloroquine plus favipiravir drug regimen in comparison with hydroxychloroquine plus kaletra on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study
Public title
Comparison of the safety and efficacy of Favipiravir and kaletra in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
Requiring hospitalization because of: Patient's oxygen saturation less than 93% OR
Requiring hospitalization because of: GCS score less than 15 OR
Requiring hospitalization because of: systolic blood pressure less than 100 or 30 mmHg decrease in systolic blood pressure from the level prior to current illness OR
Requiring hospitalization because of: renal failure (creatinine 1.5 times the previous measurement in the last 7 days OR
Requiring hospitalization because of: liver failure (AST and ALT 3 times upper limit of normal)
Patient's age between 16 and 100 years
Signed informed consent form.
Exclusion criteria:
Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir, ...)
Chronic liver failure
Chronic Renal Failure
Patients with acute problems whose survival is expected to be less than 48 hours
HIV patients
A history of gastrointestinal bleeding
Pregnancy and lactation
QT interval exceeds 500 ms
Age
From 16 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
324
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use block randomization methods using variable block size of four and six stratified by center. We will use Excel software and rand() function to generate the random sequence. The master randomization list will be kept by the epidemiologist working wit the research team.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran university of medical sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.IUMS.REC.1399.065
2
Ethics committee
Name of ethics committee
Baqiyatallah university of medical sciences
Street address
Tehran, Vanak Square, Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-03-26, 1399/01/07
Ethics committee reference number
IR.BMSU.REC.1399.017
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Admission to intensive care unit
Timepoint
Once (when admitted to intensive care unit)
Method of measurement
Hospital records
Secondary outcomes
1
Description
In-hopital mortality
Timepoint
once
Method of measurement
Patient medical records
2
Description
length of stay in hospital
Timepoint
Once at discharge
Method of measurement
Patient medical records
3
Description
Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area
Timepoint
CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the first one
Method of measurement
Patient CT scan
4
Description
Laboratory Treatment Response; return of blood cell count and CRP values to normal
Timepoint
Daily
Method of measurement
Laboratory kits
5
Description
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Timepoint
4 times a day while in the wards
Method of measurement
Observation
6
Description
Oxygen therapy maximum flow during the day (lit/min)
Timepoint
Daily
Method of measurement
Patient medical records
7
Description
Allergic drug reaction
Timepoint
Daily
Method of measurement
Adverse Drug Reaction forms
8
Description
Adverse drug reactions
Timepoint
Daily
Method of measurement
Adverse Drug Reaction forms
9
Description
Clinical improvement
Timepoint
Daily
Method of measurement
One of the following may happen to the patient: Oxygen saturation reaches above 93% and stays above 93%, the patient does not need oxygen therapy and stays in the same position, discharge by the treating physician
Intervention groups
1
Description
Intervention group: Group receiving Favipiravir plus Hydroxychloroquine. Stat dose of eight 200 mg Favipiravir tablets (total 1600 mg) and stat dose of two 200mg Hydroxychloroquine tablets (total 400 mg) followed by Favipiravir 600 mg three times a day for 7 days. This regimen could be continued for 10 days if necessary according to clinical response of the patient. Other supportive and routine care will be the same in both groups.
Category
Treatment - Drugs
2
Description
Control group: Group receiving Kaletra plus Hydroxychloroquine regimen. Stat dose of two 200 mg Hydroxychloroquine tablets (total 400 mg) followed by Kaletra(Lopinavir/Ritonavir) 200/50 mg two times a day for 7 days. This regimen could be continued for 10 days if necessary according to clinical response of the patient. Other supportive and routine care will be the same in both groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah university of medical sciences
Full name of responsible person
Dr Behzad Einollahi
Street address
Tehran, Vanak Square, Mulla Sadra Street, Sheikh Bahai Street